Policy brief

Efforts to build capacity in research ethics: an overview

Summary

During the past five years there has been a dramatic increase in the number and
type of initiatives to build capacity in research ethics in developing
countries. In this policy brief Sue Eckstein gives an overview of such
initiatives, and indicates that there is unlikely to be a “best way” to build
capacity. Instead, many different routes may lead to enhanced levels of
understanding about research ethics.

Introduction

During the past five years there has been a dramatic increase in the number
and type of initiatives to build capacity in research ethics in developing
countries. In addition to new websites, listservs, workshops and diplomas,
several Masters courses and research ethics fellowships have emerged. Training
can be largely theoretical, as with bioethics Masters degrees or predominantly
practical, as with some of the training provided to members of research ethics
committees.

As well as these formal initiatives, there appears to be a growth in
collaborations, initiated through personal contact, between research
institutions and academics and other research ethics specialists. For example,
one participant at a short course at King’s College London requested the
collaboration of King’s College academics on an International Union Against
Tuberculosis and Lung Disease workshop on research ethics. Such partnerships are
likely to increase as a result of the widening global network, and are in
themselves a measure of the growing success of the various capacity building
initiatives that have been taking place.

That capacity in research ethics in developing countries needs to be
increased does not seem to be in dispute. There are, however, differing opinions
about which type of capacity building is the most effective and sustainable,
which professionals are most usefully trained (for example, research scientists,
anthropologists or local health workers), and where training is best provided.

Funders appear to have quite rigid guidelines concerning the kind of
initiatives they will fund and the levels of funding that can be allocated. This
could result in an abundance of capacity-building initiatives that are all
broadly similar, with few smaller, more innovative or experimental initiatives
that do not follow the more common models. However, it is possible that as more
professionals in developing countries are trained in research ethics, they will
be in a good position to listen to what is needed at the local level and access
funds for such initiatives.

This policy brief aims to give an
overview of the various initiatives to build capacity in research ethics in
developing countries, and to provide details of where to access more detailed
information about particular types of programmes.

The conferences and symposia held by these organisations offer members the
opportunity to network and share strategies for good practice. For example, in
February 2002, PABIN held a symposium entitled “Good Ethical Practices in Health
Research in Africa” in Cape Town. And in December 2003, FERCAP staged a
conference examining the role of ethics committees in contributing to the
development of health research in Asia and the Western Pacific.

Increasingly, the World Health Organisation (WHO) is supporting improved
ethical standards and review processes for research involving human beings.
Several departments have undertaken training programmes for researchers and
research ethics committees, and have supported other capacity-building
initiatives at local, regional and international levels. For example, the Pan
American Health Organisation (PAHO) recently hosted the Fourth Global Forum on
Bioethics in Research in Brazil.

The Wellcome Trust’s Ethics of Biomedical Research in Developing Countries
grant scheme shares this commitment to building research capacity, and aims to
increase the number of experts with the experience and training needed to
address ethical questions raised by such research. Its new research funding
initiative supports project grants, research studentships and seminars among
other capacity-building initiatives.

The Special Programme for Research and Training in Tropical Diseases (TDR) is
also addressing the need to build capacity in research ethics. February 2004 saw
the appointment of the first Fellow recruited in connection with TDR
capacity-building activities in research ethics. It is a joint initiative in
collaboration between the TDR’s research capacity training unit, the Ethics and
Health Initiative at WHO, and SIDCER.

The ‘critical mass’ concept

It is the perceived need for focused and sustained capacity development in
the field of research ethics in developing countries that has led to the
creation of year-long courses in bioethics funded by institutions such as the
Fogarty International Centre (FIC), the US National Institutes of Health (NIH)
and the TDR.

The FIC has awarded grants to a number of institutions, enabling students
from developing countries to undertake Masters degrees and fellowships in
bioethics (see box). In nearly all cases, research ethics is a significant
component of the courses, and common to most of them is a practical assignment
in the student’s home country. Case Western Reserve University, for example, is
currently training students from Nigeria, Romania, Russia and Uganda.

Examples of FIC-funded training
initiatives

The University of Cape Town’s Centre for Bioethics has received an FIC grant
to support international bioethics education for four years through its
International Research Ethics Network for South Africa (IRENSA). The
programme aims to train a cohort of twelve students each year with the intention
of producing a critical mass of mid-career faculty trained in research ethics
for the Southern African regions.

The South African Research Ethics Training Initiative (SARETI) is a
training programme for scientists, academics and members of research ethics
committees, based at the Universities of KwaZulu-Natal and Pretoria. The
initiative awards scholarships for Masters degree study and fellowships for
shorter periods of formal study or sabbaticals not for degree purposes. The
multidisciplinary programme has representation from medical sciences, social
sciences, philosophy, ethics and law.

The University of Toronto’s Joint
Centre for Bioethics (JCB) was also awarded an FIC bioethics research and
education grant. It undertook to train 16 mid-career professional from
developing countries, with an emphasis on South Asia and Africa. According to
the course convenors, its graduates have gone on to teach bioethics in their
home institutions, change public policy in healthcare or introduce practical
training into their workplaces. They have also been active in publishing, and in
applying for further FIC grants to train more graduates in their home countries.
The programme has also supported emerging programmes in developing countries by
providing advice, site visits and faculty membership.
[1]

The ‘cascade’ effect of such programmes should
not, according to their champions, be underestimated. A recent progress report
described how “in the three years [the Johns Hopkins - Fogarty African Bioethics
Training Program] has existed, the nine trainees who have returned to Africa
collectively have given approximately 50 invited presentations on ethics at
national or international meetings, have helped create four IRBs, have improved
the quality of several others, have consulted to four international research
projects, have received one grant from an international agency for ethics, and
have had one manuscript accepted by a peer reviewed international ethics
journal.” [2]

It could be argued that this top-down method of providing research ethics
training in developed countries to professionals from developing nations is
inappropriate and could constitute a kind of ethical imperialism. This issue has
been debated by many of the providers of training including Peter Singer of the
University of Toronto JCB. While Singer recognises that “the actual capacity
needs of a developing country or region are best met (both on grounds of cost
effectiveness and cultural appropriateness) by supporting centres and training
programmes in developing countries,” he argues that “these centres and
programmes themselves need support to build a critical mass of highly trained
faculty so they can be highly successful and sustainable.” [3] He is confident
that Northern centres like Toronto have a defined and important role to play in
a global programme of bioethics capacity strengthening.

Cross-fertilisation: faculty exchanges and collaboration

Faculty exchange is something that has become an integral part of many
bioethics courses. For example, JCB works with the bioethics programme at the
University of Cape Town, with staff from Cape Town teaching in Toronto and vice
versa. JCB has also been able to strengthen the FIC-funded Centre for the AIDS
Programme of Research in South Africa (CAPRISA), based at the University of
Natal, by training a lawyer and social scientist who are working to develop
research ethics in the context of HIV.

Similarly, SARETI collaborates with its South African partner IRENSA at
various levels in improving research ethics capacity in the region. SARETI is
also forging alliances with initiatives to advance research ethics capacity in
Francophone African countries.

Although much capacity-building activity is concentrated in Africa and Asia,
or is intended for students from those regions, there are also some effective
initiatives in Latin America. The Training Programme in Research Ethics in the
Americas is a flourishing collaboration between Albert Einstein College of
Medicine in the United States and the University of Buenos Aires, which aims to
establish a network in research ethics in Latin America.

Trainees from any
country in Central or South America spend seven months in Buenos Aires and,
during this time, develop a plan for introducing research ethics into the
institution to which they will return. According to the co-directors, Ruth
Macklin and Florencia Luna, informal tracking indicates that the first set of
four trainees have begun new activities in research ethics in Peru, Costa Rica,
Argentina and Guatemala.

Ongoing support and training

Since these kinds of initiatives can train only a limited number of people,
the success of each programme is highly dependent on how well trainees can
sustain their ethics work on their return to their home countries.

For example, the nine alumni of the Johns Hopkins University (JHU) initiative
have a biennial reunion to allow for feedback once they have returned to the
field. An electronic newsletter is produced quarterly, which trainees are
encouraged to distribute to local colleagues and research ethics committee
members. JHU also emails former trainees every month to inquire about their
ethics related activities and sends regular email bulletins listing relevant
articles and grant announcements. This kind of activity is a time-consuming but
invaluable way of ensuring sustainability.

Other initiatives are also
committed to sustainability. For example, in four years’ time SARETI aims to
arrange an Africa-wide health research ethics symposium in collaboration with
other African ethics organisations. This event is intended to increase the
impact and networking potential of SARETI training programmes, facilitate
African exchange in health research ethics, strengthen Africa’s voice in the
field and offer trainees the opportunity to present work to their peers.
Meanwhile, the Training Programme in Research Ethics in the Americas undertakes
to provide continual support for trainees once they return to their home
countries, for example by providing them with laptop computers.

Intensive training initiatives

While many capacity-building initiatives take place over the course of an
academic year and train relatively few individuals, workshops and short courses
in research ethics give a large number of participants the chance to immerse
themselves in the subject and network with both faculty and peers. These short
courses can be an effective way of building capacity in research ethics in
developing countries, particularly for participants who may not be able to
commit more than a few days or weeks to training, or may not have the academic
credentials to qualify for a Masters or Diploma course of study.

Harvard School of Public Health has, to date, held fifteen four-day workshops
on “Ethical Issues in International Health Research” in eight countries, in
which 700 participants have received a grounding in research ethics. A major
factor in the workshops’ success appears to be the resources that are provided
both during the workshop and afterwards.

These workshops make extensive use of cases, many of which are on the Harvard
website, along with interactive discussions. Effective follow-up of past
participants also enables workshop organisers to analyse how their alumni have
put the theory into practice, and to respond to participants’ needs when
planning future workshops (see box). [4]

Sample comments from participant evaluation
forms

“I have used materials obtained from the course in presentations at the
research centre where I work. I have improved my supervision of research
assistants and field workers…I plan to compile the materials into a handy manual
for use by lay IRB members.”

“I have designed and conducted two workshops on research ethics in Hanoi,
Viet Nam using the format of case study discussion. This is I believe the best
way of getting people to think about ethics and ethical issues. Though I use the
case study design, I have adapted the actual studies to match local interest. I
have used the format also in a workshop in Zimbabwe. There is a definite
increasing awareness of the need for ethical review in the research
programme.”

There are many other short training initiatives, such as the five-day course
in Metro Manila, run by the University of the Philippines and funded by the FIC.
Additionally, some of the institutions that specialise in year-long training
also provide short courses. These are targeted at professionals already working
in research ethics, who may be in positions of influence. For example, a
one-month training programme was started at JHU in June 2003 for trainees from
SARETI.

SARETI itself runs a three-week course for members of South African research
ethics committees, and the Training Programme in Research Ethics in the Americas
also offers two one-week intensive seminars in Buenos Aires each year, open to
members of ethics committees in the city and beyond.

One-off workshops that are devised by Western academics and held in
developing countries can be useful in raising awareness about ethics and
stimulating dialogue about the importance of ethical review, provided
participants arrive with a commitment to research ethics and the support and
infrastructure in their home institutions to allow them to put their learning
into practice.

However, it has been argued by Nancy Kass of JHU that “short
workshops cannot effect a sustained impact on their own… Without sustained
local presence, it is unrealistic to imagine that ethics training
ultimately will have much impact. And to state the obvious, it is both
impractical and inappropriate for that role to be served by a transient
professional from the outside.”

Conclusion

There are several exciting and effective initiatives to build capacity in
research ethics in developing countries. Crucial to their success appears to be
easily accessible information about courses, forums and networks; adequate
funding to institutions and students; the provision of comprehensive and
comprehensible course material which can be freely accessed and replicated both
during and after training; and ongoing and transparent evaluation of courses and
other initiatives.

Graduates of Masters and diploma courses and participants on short research
ethics courses need to have a personal and institutional commitment to research
ethics, a supportive environment in which to function once the training is over,
and continuing support and assistance from their training institutions.

However, as none of the capacity-building programmes has been in existence
for long – and there is no detailed or systematic evaluation of them in the
public domain – it is difficult to give evidence to support claims about impact
or effectiveness at present. It is therefore important that effective evaluation
of the programmes is undertaken and that the results and conclusions be in the
public domain.

What is clear, is that there is unlikely to be a “best way” to build
capacity. Instead, many different routes may lead to enhanced levels of
understanding about research ethics.

Acknowledgements

The author would like to thank
the many course convenors, centre directors and others who have been extremely
helpful in giving access to information, some of which is not yet widely
available.

Sue Eckstein is a research fellow at the Centre of Medical Law and Ethics,
King’s College London. She is responsible for the management and development of
short courses and advanced study days on the ethics of research on humans, the
editing of the Manual for Research Ethics Committees, and Centre initiatives
relating to developing countries.

References

1] Singer, P. (2004) University of Toronto MHSc in Bioethics International
Stream, NIH grant application
[2] Kass, N. (2003) Grant Resubmission, PHS
398/2590
[3] Singer, P. (2004) University of Toronto MHSc in Bioethics
International Stream, NIH grant application
[4] Program on Ethical Issues in
International Health Research. Evaluation June 1999-Sept 2001 (Department of
Population and International Health Research, Harvard School of Public
Health)